Prosthetic socket system

ABSTRACT

A prosthetic socket system includes a prosthetic lock assembly having a lock body defining a pin hole adapted to receive an attachment pin, and a locking device in the lock body. The locking device is engageable with the attachment pin to unidirectionally lock the attachment pin in the lock body while permitting insertion of the attachment pin in the lock body. A valve assembly is positioned in the lock body that is movable between a closed position and an open position in which the valve assembly is unsealed so that air moves into the lock body via the valve assembly. A release mechanism positioned in the lock body is arranged to both release the locking device from the attachment pin and move the valve assembly to the open position by translating the locking device in the lock body.

TECHNICAL FIELD

The disclosure relates to prosthetic socket systems including one ormore suspension mechanisms for securing a prosthetic socket to aresidual limb.

BACKGROUND

A typical prosthetic leg and foot includes a socket, pylon, and foot. Asocket is commonly referred to as the portion of a prosthesis that fitsaround and envelops a residual limb or stump, and to which prostheticcomponents, such as a foot, are attached. The socket must fit closely tothe residual limb to provide a firm connection and support but must alsobe sufficiently loose to allow for circulation. In combination withproper fitting, the socket must transfer loads from the residual limb tothe ground in a comfortable manner.

To increase comfort, it may be provided that a prosthetic liner isarranged between the socket and the residual limb. In general, theprosthetic liner includes an elastomeric body having a closed distal endand an open proximal end that is pulled or rolled over the residuallimb. The prosthetic liner adheres to the residual limb surface andgenerates the connection between the residual limb and the socket.

Different mechanisms exist for holding the socket on the residual limbduring use of the prosthesis. For instance, locking suspension providesan attachment pin at the distal end of the prosthetic liner and acorresponding prosthetic attachment lock at the distal end of thesocket, which mechanically locks the prosthetic liner to the socketafter insertion into the socket. While providing a secure connectionbetween the socket and the residual limb, this mechanical lock can leadto skin problems and stability issues. For instance, the attachment pinonly attaches to the socket in the distal end of the socket at a point,which can cause unwanted movement as the prosthetic liner stretches whentaking up loads during gait. This point connection can result in“milking” where the distal end of the residual limb is pulled a littlein every step, which, in turn, can lead to skin problems, such asstretching of the tissues at the limb residuum and swelling,inflammation, distortion, and pain, among others.

Mechanical locking systems can also result in “pistoning” or exaggeratedin-and-out motion of the residual limb in the socket, which, in turn,can cause additional friction and shear that may lead to skin chafingand blistering. Such locking suspension systems may additionally lead tostability or rotational issues if the socket is not fitting tightlyenough.

Another mechanism for attaching a socket to a residual limb resides inwhat is known as a vacuum lock or vacuum suspension, in which the socketseals airtight against the prosthetic liner and air present in the spacebetween the prosthetic liner and the socket is pulled or forced out.This creates a suction tending to retain the residual limb within thesocket, reduce pistoning, and improve stability. Disadvantageously,however, vacuum suspension can only be used with sockets that areairtight and thus is considered a less reliable suspension mechanism.For instance, the strength and reliability of the seal attaching thesocket to the residual limb can be impaired and/or broken due toirregular loading of the socket by the user, excessive relative movementbetween the prosthetic liner and the socket, perspiration, and/or otherfactors. This can compromise suspension and, in the worst case, cancause the prosthesis to fall off, which, in turn, increases thelikelihood of injury and user doubt. In addition, fitting a socket to auser for vacuum suspension is generally more complicated and expensivethan for mechanical locking suspension.

Additionally, traditional vacuum suspension systems may not be availableto all users; for example, users with shorter residual limbs may not beable to use existing vacuum suspension systems because of air channelingthrough the shorter distance, leading to loss of vacuum and potentiallycatastrophic failure of the attachment. Vacuum systems may further beundesirable or impractical for elderly users.

Thus, existing prosthetic socket systems must choose between twoimperfect option: a mechanical lock that is reliable but unstable anduncomfortable against a user's skin, or a vacuum lock that is morecomfortable and stable but less reliable. Accordingly, there is a needfor an improved prosthetic socket system that provides more reliable andstable prosthetic suspension with reduced risk of skin problems andother injuries.

SUMMARY

Embodiments of the present disclosure can include a prosthetic socketsystem having a prosthetic lock assembly with a lock body defining a pinhole adapted to receive an attachment pin associated with a prostheticliner, and a locking device in the lock body. The locking device isengageable with the attachment pin to unidirectionally lock theattachment pin in the lock body while permitting insertion of theattachment pin in the lock body. A valve assembly is positioned in thelock body that is movable between a closed position and an open positionin which the valve assembly is unsealed so that air moves into the lockbody via the valve assembly.

A release mechanism positioned in the lock body is arranged to bothrelease the locking device from the attachment pin and move the valveassembly to the open position by translating the locking device in thelock body. This beneficially facilitates doffing of a socket as goodhand dexterity and/or strength are not required to operate theprosthetic lock assembly. Rather, a prosthetic liner can be securelyattached to the socket and easily released from the socket using theprosthetic assembly with a simple manipulation of the release mechanism.Moreover, the release mechanism may be arranged to do so in a singleaction, minimizing the cost and complexity of the prosthetic socketsystem according to the disclosure.

The prosthetic lock assembly also isolates the mechanical lock betweenthe prosthetic liner and the portion of the socket extending from thesocket cavity proximal to the prosthetic lock assembly, which, in turn,allows for the formation of a vacuum lock between the prosthetic linerand the socket. The vacuum lock can provide a larger attachment area orattachment length between the prosthetic liner and the socket than thatprovided by the attachment pin alone. This reduces the likelihood ofproblems that can result when the attachment pin pulls on the distal endof the prosthetic liner.

For instance, the larger attachment area of the vacuum lock presses orholds the socket and the prosthetic liner together over a larger area ofthe prosthetic liner, not just at the attachment pin, reducing thelikelihood of pistoning and milking between the residual limb and thesocket. It also helps improve rotational control and stability of theprosthetic socket system because the socket and the prosthetic liner aremore likely to move together rather than rotate or displace relative toone another during use of the prosthetic socket system. Further, if thevacuum lock is unexpectedly reduced or lost, the mechanical lock betweenthe attachment pin and the socket reliably keeps the socket attached tothe prosthetic liner, preventing the socket from falling of the residuallimb. In this way, the prosthetic socket system of the disclosureachieves the benefits of mechanical locking and vacuum locking systemswhile avoiding the respective drawbacks of each system.

Moreover, the vacuum and mechanical locks or dual suspension mechanismsof the present disclosure can benefit a wide range of users. Forinstance, below-the-knee amputees can comfortably use the prostheticsocket system to enjoy the comfort and stability of vacuum suspensionwithout having to worry about their prosthesis falling off. Furthermore,higher activity users can move more confidently using the prostheticsocket system in challenging situations like cycling, running, andclimbing, owing to the enhanced security offered by the dual suspensionmechanisms. In addition, elderly or lower activity users can comfortablyand confidently use the prosthetic socket system without having to worryabout undesirable pistoning or about a loss of suspension while the useris sitting or kneeling, and further without experiencing the skinproblems and pain of existing systems.

The dual suspension mechanisms of the present disclosure additionallycan benefit clinicians in the recommendation and fitting of prostheticsocket systems. Clinicians often do not feel confident providing moreelderly patients with vacuum suspension because the patient tends toworry about the socket falling off. With the dual suspension systems ofthe present disclosure, clinicians can offer these patients a safesolution and at the same time the benefits of vacuum suspension.Clinicians also tend to shorten the fit of a socket on a residual limbusing a locking liner because of friction concerns associated withundesirable pistoning. With the dual suspension mechanisms of thepresent disclosure which minimize such drawbacks, clinicians can alignthe residual limb length more correctly with a length of the socket, notshorter per certain existing systems and practices to compensate forpistoning, because of the reduced risk of pistoning. This helps improvethe fit and support of the socket.

Exemplary embodiments of the present disclosure further describe adistal seal, with a variable clearance and flexibility, adapted to forma seal around the attachment pin. Other embodiments describe an improvedprosthetic socket system for allowing fluid flow in desired directionsand patterns within the prosthetic socket system

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure will become better understood regarding the followingdescription, appended claims, and accompanying drawings.

FIG. 1 shows an elevational view of a cross section of a prostheticsocket system according to an embodiment.

FIG. 2 shows a perspective view of a prosthetic socket system accordingto another embodiment.

FIG. 3 shows a cross section of the distal seal of FIG. 2 in anelevational view.

FIG. 4 shows the distal seal of FIG. 2 in a perspective view.

FIG. 5 shows a cross section in an elevational view of a distal sealaccording to another embodiment.

FIG. 6 shows a perspective view of a prosthetic socket system accordingto another embodiment.

FIG. 7 shows a cross section of the distal seal of FIG. 6 in anelevational view.

FIG. 8 shows a perspective view of a prosthetic socket system accordingto another embodiment.

FIG. 9 shows a cross section of the distal seal of FIG. 8 in anelevational view.

FIG. 10 shows a perspective view of a prosthetic socket system accordingto another embodiment.

FIG. 11 shows a cross section of the distal seal of FIG. 10 in anelevational view.

FIG. 12 shows a partial cross section in an elevational view of aprosthetic socket system according to another embodiment.

FIG. 13 shows a cross section in a plan view of the prosthetic lockassembly of FIG. 12 .

FIG. 14A shows a cross section in an elevational view of the prostheticlock assembly of FIG. 12 in a first position.

FIG. 14B shows a detail view of the cross section of the prosthetic lockassembly of FIG. 14A.

FIG. 15A shows a cross section in an elevational view of the prostheticlock assembly of FIG. 12 in a second position.

FIG. 15B shows a detail view of the cross section of the prosthetic lockassembly of FIG. 15A.

FIG. 16A shows a cross section in an elevational view of the prostheticlock assembly of FIG. 12 in a third position.

FIG. 16B shows a detail view of the cross section of the prosthetic lockassembly of FIG. 16A.

FIG. 17A shows a cross section in an elevational view of the prostheticlock assembly of FIG. 12 in a fourth position.

FIG. 17B shows a detail view of the cross section of the prosthetic lockassembly of FIG. 17A.

FIG. 18 shows a prosthetic view of a prosthetic socket system accordingto another embodiment.

FIG. 19 shows a partial detailed view of the prosthetic liner of FIG. 18.

FIG. 20 shows a bottom view of the prosthetic liner of FIG. 18 .

FIG. 21 shows a bottom view of a prosthetic liner according to anotherembodiment.

The drawing figures are not necessarily drawn to scale, but instead aredrawn to provide a better understanding of the components, and are notintended to be limiting in scope, but to provide exemplaryillustrations. The figures illustrate exemplary configurations ofprosthetic socket systems, and in no way limit the structures orconfigurations of a prosthetic socket system and components according tothe present disclosure

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the disclosure may behad from the following description read with the accompanying drawingsin which like reference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are in thedrawings and are described below. It should be understood, however,there is no intention to limit the disclosure to the specificembodiments disclosed, but on the contrary, the intention covers allmodifications, alternative constructions, combinations, and equivalentsfalling within the spirit and scope of the disclosure.

It will be understood that unless a term is expressly defined in thisapplication to possess a described meaning, there is no intent to limitthe meaning of such term, either expressly or indirectly, beyond itsplain or ordinary meaning.

Embodiments of the present disclosure advantageously combine vacuum andlocking suspension to enhance the reliability, stability, and comfort ofthe attachment between the residual limb and the socket. FIG. 1illustrates a prosthetic socket system 100 according to an embodimentincluding a socket 102, a prosthetic liner 104, and a prosthetic lockassembly 106. The socket 102 has an outer surface 110 and an opposinginterior surface 112 defining a socket cavity 114. The socket cavity 114includes an open proximal end and a distal end 116. The open proximalend is adapted to receive a distal portion of a residual limb 118 toinserted in the socket cavity 114. The distal end 116 includes a pinbore 120 extending therethrough.

The prosthetic liner 104 is configured to be donned on the residual limb118 and positioned in the socket cavity 114. Typical liners are made ofsoft, stretch material and protect the residual limb 118 and act as aninterface between the harder, weight bearing socket 102 and the skin ofthe residual limb 118. The prosthetic liner 104 includes a liner body122 having a proximal end, which is open, and a distal end 124, which isclosed. The liner body 122 defines an inner surface that interfaces withthe skin, and an outer surface 128 opposing the inner surface. The linerbody 122 can be formed of a polymeric or elastomeric material likesilicone, copolymer gel, polyurethane, combinations thereof, or anyother suitable material.

An attachment pin 130 is secured to the distal end 124 of the prostheticliner 104. The attachment pin 130 can define a plurality of notches orcan be smooth. The attachment pin 130 may be mounted to the prostheticliner 104 by being molded or threaded onto the distal end 124 of theprosthetic liner 104. The attachment pin 130 is positioned to extendthrough the pin bore 120 of the socket 102 and thus through the distalend 116 of the socket 102.

The attachment pin 130 engages the prosthetic lock assembly 106 that mayor may not be laminated into the socket 102. The prosthetic lockassembly 106 is arranged to connect to prosthetic components (e.g., apylon system, socket adapters, or a prosthetic foot) and effectivelycouples the prosthetic liner 104, the socket 102, and the othercomponents together. When the attachment pin 130 passes through the pinbore 120 of the socket 102, the prosthetic lock assembly 106 can receiveand lock the attachment pin 130 therein, which, in turn, mechanicallycouples the prosthetic liner 104 to the socket 102. This mechanical lockor attachment of the prosthetic liner 104 to the socket 102 can bereleased via a release mechanism 126 of the prosthetic lock assembly106. The mechanical lock thus provides a user with safe and reliablesuspension.

In addition to the mechanical lock provided by the prosthetic lockassembly 106, the prosthetic socket system 100 can include a sealingsystem 103 configured to isolate a distal end portion of the socketcavity 114 from atmosphere after the prosthetic liner 104 has been fullyinserted within the socket 102, which, in turn allows a vacuum orsuction to be generated between the prosthetic liner 104 and the socket102 for vacuum suspension in supplement to the mechanical lock providedby the prosthetic lock assembly 106.

The sealing system 103 can include at least a first seal component 107.The first seal component 107 can comprise a distal seal 108 positionedat or near the distal end 124 of the prosthetic liner 104 and configuredto create a first seal around the mechanical lock between the socket 102and the prosthetic liner 104. For instance, this first seal can seal offthe prosthetic lock assembly 106, including the attachment pin 130extending through the pin bore 120 in the socket 102, thus preventingair from entering or exiting the socket cavity 114 via the pin bore 120.

The sealing system 103 can include a second seal component 141. Thesecond seal component 141 can be associated with the prosthetic liner104 and/or the socket 102 and is arranged to create a second sealbetween the prosthetic liner 104 and the socket 102 that is locatedproximal to the first seal. The second seal component 141 can be at anylocation along a length of the prosthetic liner 104 and may beconfigured and positioned at a position to create an attachment area orattachment length L over which a vacuum lock is effective to retain theprosthetic liner 104 within the socket 102. For instance, the secondseal component 141 can be located about halfway between the proximal anddistal ends 124 of the prosthetic liner 104. The second seal component141 can include one or a plurality of seals and can comprise a hypobaricseal, a membrane, or any other suitable seal component.

In other embodiments, the second seal component 141 can be compatiblewith prosthetic sleeves. The second seal component 141 can comprise anadjustable seal component. In an embodiment, the location of the secondseal component 141 can be adjustable along the length of the prostheticliner 104. The second seal component 141 can be formed on the prostheticliner 104. Other examples of suitable seal components are found in U.S.Pat. Nos. 8,308,817; 8,097,043; 8,052,760; 8,034,120; 8,372,159;8,372,159; 8,894,719; 8,956,422; 8,911,506; 9,056,022; 9,072,611;9,060,885; 9,066,821; 9,295,567; 9,566,175; and 9,707,106, each of whichis incorporated herein by reference in its entirety.

A sealed volume or suspension region A is defined between the first sealcomponent 107 and the second seal component 141, and between at least aportion of the outer surface 128 of the prosthetic liner 104 and acorresponding portion of the interior surface 112 of the socket 102,substantially isolating this area from atmosphere and the mechanicallock between the prosthetic liner 104 and the socket 102.

To permit expulsion of fluid (e.g., air) from the suspension region A, aport 132 can be defined by the socket 102 that extends through theinterior surface 112 and the outer surface 110 of the socket 102. Thesuspension region A is fluidly connected with atmosphere external to thesocket 102 via the port 132. A valve may be provided separately orintegrally with the port 132. The valve can be a one-way valve thatselectively permits fluid to flow from the suspension region A throughthe port 132 to atmosphere external to the socket 102, but not in theother direction.

According to a variation, a pump system 134 may be fluidly connectedwith the suspension region A. The pump system 134 can be fluidlyconnected with the suspension region A via a tube 136 connected to theport 132. The pump system 134 can be any suitable type of pump such as amanual or electrical pump. The pump system 134 can create an elevatedvacuum environment in the suspension region A, which, in turn, providesa suction tending to retain the residual limb 118 within the socket 102.

The suspension region A provides a larger attachment area or attachmentlength L between the prosthetic liner 104 and the socket 102 than thatprovided by the attachment pin 130 alone. This has the effect ofreducing the likelihood of problems that can result when the attachmentpin 130 pulls on the distal end 124 of the prosthetic liner 104, such as“milking,” “pistoning,” and attendant problems, as well as stability androtational issues resulting from a poor fit between the socket 102 andthe prosthetic liner 104.

The larger attachment area of the suspension region A pulls or holds thesocket 102 and the prosthetic liner 104 together over a larger area ofthe prosthetic liner 104, not just at the attachment pin 130, reducingthe likelihood of pistoning and milking between the residual limb 118and the socket 102. It also helps improve rotational control andstability of the prosthetic socket system 100 because the socket 102 andthe prosthetic liner 104 are more likely to move together rather thanrotate or displace relative to one another during use.

Further, if the vacuum or suction in the suspension region A isunexpectedly reduced or lost, the mechanical lock between the attachmentpin 130 and the socket 102 reliably keeps the socket 102 attached to theprosthetic liner 104, preventing the socket 102 from falling off theresidual limb 118 and engendering greater user confidence. For example,patients or users with shorter residual limbs are often unable toconfidently use prosthetic socket systems employing vacuum suspensionbecause of a higher risk of air channeling between the prosthetic linerand the socket. With the mechanical lock between the attachment pin 130and the socket 102 reliably attaching the socket 102 to the residuallimb 118, these users can benefit from the stability and comfort offeredby the sealing system 103 without worrying about the socket 102 fallingoff due to air channeling, for example as occurs in some existingvacuum-only suspension systems.

Accordingly, by attaching the socket 102 to the residual limb 118 usingboth the attachment pin 130 and suction in the sealed volume A, theprosthetic system 100 advantageously combines the benefits and reducesthe shortcomings of both suspension mechanisms. Further, users of theprosthetic system 100 can experience an increased perception ofsuspension and stability when compared to prior art systems including asingle suspension mechanism.

As discussed, the vacuum and mechanical locks or dual suspensionmechanisms of the prosthetic socket system 100 can benefit a wide rangeof users. For instance, below-the-knee amputees can comfortably use theprosthetic socket system 100 to enjoy the comfort and stability ofvacuum suspension provided by the sealing system 103 without having toworry about their prosthesis falling off. Furthermore, higher activityusers can move more confidently using the prosthetic socket system 100in challenging situations like cycling, running, and climbing. Inaddition, elderly or lower activity users can comfortably andconfidently use the prosthetic socket system 100 without having to worryabout undesirable pistoning or about a loss of suspension while the useris sitting or kneeling.

With the dual suspension mechanisms of the prosthetic socket system 100,clinicians can offer elderly patients a safe mechanical solution to theproblem of sockets falling off and at the same time the benefits ofvacuum suspension. Clinicians also tend to shorten the fit of a socketon a residual limb used with a locking liner because of frictionconcerns associated with undesirable pistoning. With the dual suspensionmechanisms of the prosthetic socket system 100, clinicians can align theresidual limb length more correctly with a length of the socket 102, notshorter to compensate for pistoning because of the reduced risk ofpistoning provided by the sealing system 103. This helps improve the fitand support of the socket 102.

In an embodiment, the distal seal 108 has a flexible configuration andis positioned at or near the distal end 124 of the prosthetic liner 104.The distal seal 108 extends circumferentially around the attachment pin130 and projects downwardly from a distal portion of the outer surface128 of the prosthetic liner 104. The distal seal 108 can include asealing portion and a variable clearance defined between the sealingportion and the distal end 124 of the prosthetic liner 104. When theprosthetic liner 104 is inserted into the socket 102, the variableclearance and a flexibility of the distal seal 108 allow the sealingportion of the distal seal 108 to deflect and deform, bridging a sealbetween the distal outer surface 128 of the prosthetic liner 104 and thedistal interior surface 112 of the socket 102.

The variable clearance and flexibility of the distal seal 108 helps thedistal seal 108 compensate for relative movement between the socket 102and the prosthetic liner 104 by allowing the sealing portion to bettermove with and exert pressure against the distal interior surface 112 ofthe socket 102 to improve the seal bridged between the socket 102 andthe prosthetic liner 104. This seals off the attachment pin 130extending through the pin bore 120 of the socket 102, preventing airfrom entering or exiting the socket cavity 114 via the pin bore 120. Italso isolates the mechanical lock between the prosthetic liner 104 andthe socket 102 from the socket cavity 114 extending proximal to thedistal seal 108, which, in turn, allows for vacuum (passive or active)to build up between the socket 102 and the liner 104 as shown in FIG. 1. The distal seal 108 thus advantageously helps the system 100 to formboth a mechanical lock and a vacuum lock between the prosthetic liner104 and the socket 102, securing the connection between the residuallimb 118 and the socket 102.

The prosthetic socket system 100 can thus beneficially provide a morereliable and stable connection between the socket 102 and the prostheticliner 104 by combining mechanical and vacuum suspension mechanisms.Moreover, the distal seal 108 can be a separate add-on module to alocking liner and can fit different liners, providing versatility andreducing costs of implementing the prosthetic socket system 100.

FIGS. 2-4 illustrate another embodiment of a prosthetic socket system200 including a prosthetic liner 204 having an attachment pin 230, and asealing system 203 including a first seal component 207 arranged to forma seal around the attachment pin 230, and a second seal component 241adapted to form a second seal between the prosthetic liner 204 and asocket. Like the previous embodiment, the prosthetic liner 204 can beattached to the socket using both the attachment pin 230 and suctionbetween the first and second seals, the prosthetic liner 204, and thesocket. This allows the prosthetic socket system 200 to solve problemsthat can result when the attachment pin 230 pulls on the distal end 224of the prosthetic liner 204 or when the suction between the prostheticliner 204 and the socket is lost or reduced.

The prosthetic liner 204 is configured to be donned on a residual limband positioned in a socket. The prosthetic liner 204 includes a linerbody 222 having a proximal end, which is open, and a distal end 224,which is closed, and defines an inner surface that interfaces with theskin, and an outer surface 228 opposing the inner surface. The distalend 224 may include an umbrella 240 that enables interconnection betweenthe prosthetic liner 204 and a prosthetic device. The umbrella 240generally includes an umbrella-shaped base and a neck that depends fromthe center of the base. An internally threaded central bore is formed inthe neck. The liner body 222 may be formed of an elastomer and may ormay not include a fabric cover.

The attachment pin 230 is threaded into the central bore of the umbrella240 of the prosthetic liner 204 and can engage a prosthetic lockassembly arranged to couple the liner 204 and the socket together. Theattachment pin 230 can define a plurality of notches and/or can besmooth.

The first seal component 207 comprises a distal seal 208 attached to thedistal end 224 of the liner 204. The distal seal 208 includes a sealingportion and has a flexible configuration arranged to create the firstseal between the prosthetic liner 204 and the socket. This first sealcomponent 207 can seal off the attachment pin 230 extending through thepin bore in a socket, preventing air from entering or exiting the socketcavity via the pin bore. It also helps define a sealed volume betweenthe prosthetic liner 204 and the socket that isolates the mechanicallock between the prosthetic liner 204 from the socket's interiorproximal to the distal seal 208, which, in turn, allows for vacuum orsuction to build up between the distal seal 208, the second sealcomponent 241, the prosthetic liner 204 and the socket.

The second seal component 241 comprises a movable seal componentremovably positionable on the prosthetic liner 204. The second sealcomponent 241 includes open upper and lower ends defining an openingtherethrough and an inner surface arranged to abut the outer surface 228of the prosthetic liner 204. In an embodiment, the second seal component241 can frictionally engage at least one of a plurality of seal bands238 on the liner body 222 and secure on the outer surface 228 of theliner body 222. Similar to the previously described seal components, thesecond seal component 241 is adapted to create a second seal between theprosthetic liner 204 and a socket that is located proximal to the distalor first seal formed by the distal seal 208.

The sealing system 203 thus advantageously enables the prosthetic system200 to form both a mechanical lock and a vacuum lock between theprosthetic liner 204 and a socket, providing reliable and comfortableprosthetic suspension and minimizing the disadvantages of existingsingle-lock systems.

In the illustrated embodiment, the distal seal 208 includes a base 242and a sealing portion 256. The distal seal 208 can be attached to thedistal end 224 of the prosthetic liner 204 by being secured between theumbrella 240 and the attachment pin 230. For instance, the base 242defines a neck or stem 244 that extends from a central portion of thebase 242. The base 242 can comprise a disc, a conical member, orumbrella-shaped portion adapted to interface with and fit against theumbrella 240. The base 242 can be proximate to the attachment pin 230.An opening 246 is formed in the stem 244 for engagement with theattachment pin 230. A diameter of the opening 246 can generallycorrespond to the diameter of the attachment pin 230. The distal seal208 may be made of an air-impermeable material such as an elastomermaterial, silicone, polyurethane, or any other suitable material.

A rigid part 248 such as a washer member is associated with the stem244. The rigid part 248 can include a support base 252 defining acentral opening and annular wall 254 surrounding the support base 252.The annular wall 254 may extend either partially or entirely around anouter peripheral portion of the support base 252. In use, the rigid part248 transfers forces between the attachment pin 230 and the umbrella 240and away from the more flexible sealing portion 256 of the distal seal208. The rigid part 248 may be integrally formed with the stem 244 orseparate from the stem 244. For instance, at least the annular wall 254can extend within the stem 244 of the distal seal 208. The rigid part248 may be formed of any suitable material, including, but not limitedto, thermoplastic, polyoxymethylene (POM), metal, and/or plastic.

To attach the distal seal 208 to the distal end 224 of the prostheticliner 204, the distal seal 208 can be positioned on the umbrella 240 sothat the top of the base 242 interfaces with the distal end 224 of theliner 204. A threaded proximal end of the attachment pin 230 is thenpassed though the opening 246 of the stem 244 and screwed into thecentral bore of the umbrella 240. The attachment pin 230 is screwed intothe central bore of the umbrella 240 until a flange 250 defined on theattachment pin 230 engages with the rigid part 248 of the distal seal208, which, in turn, secures or fastens the distal seal 208 between theumbrella 240 and the attachment pin 230. An outer diameter of the flange250 can be greater than the central opening defined in the base of therigid part 248.

To remove the distal seal 208 from the prosthetic liner 204, theattachment pin 230 can be unscrewed from the central bore of theumbrella 240 and the distal seal 208 can be pulled off the umbrella 240and the attachment pin 230. The distal seal 208 can thus be quickly andefficiently installed, removed, and reconfigured with great ease. Thedistal seal 208 can be easily removed for cleaning or to be exchangedwith a replacement or another distal seal adapted for a differentapplication. Further, the distal seal 208 can be used with orretrofitted onto conventional or existing locking liners and socketswithout permanent modification of their structure.

The sealing configuration of the distal seal 208 will now be describedin more detail. As seen best in FIGS. 3 and 4 , the distal seal 208includes the sealing portion 256 comprising a wall segment 258 extendingcircumferentially and downwardly from an outer peripheral portion of thebase 242. The wall segment 258 can be angled relative to the outerperipheral portion of the base 242 and can have a conical configurationwith a decreasing diameter toward its distal end.

A variable clearance 260 is defined between the sealing portion 256 andthe prosthetic liner 204 and/or base 242. In use, a residual limb isplaced within the prosthetic liner 204 and both the residual limb andprosthetic liner 204 are inserted within a socket so that the distalseal 208 engages a distal interior surface of the socket. As the sealingportion 256 engages the distal interior surface of the socket, aflexibility of the distal seal 208 allows the sealing portion 256 todeflect toward the prosthetic liner 204 and deform, forming a sealbetween the prosthetic liner 204 and the socket. This beneficially sealsaround the mechanical lock effected by the attachment pin 230 betweenthe prosthetic liner 204 and the socket, and consequently allows for avacuum (passive or active) to be generated between the distal seal 208and the second seal component 241. The variable clearance 260 andflexibility of the distal seal 208 helps the distal seal 208 compensatefor relative movement between the socket and the prosthetic liner 204 byallowing the sealing portion 256 to better or more freely move with andexert pressure against the interior surface of the socket to improve theseal. The wall segment 258 can have an elongate configuration,increasing the surface area and consequently the effectiveness of theinterface between the sealing portion 256 and the interior surface ofthe socket.

When a higher pressure exists on the inner side of the sealing portion256 as compared to the outer side thereof (such as when a vacuum iscreated between the socket and the prosthetic liner 204), the distalseal 208 will tend to expand outwardly against the interior surface ofthe socket and a sealing force exerted by the distal seal 208 canincrease commensurately with the pressure differential. In anembodiment, a reinforcement member or the material properties of thedistal seal 208 can bias or urge the wall segment 258 away from the base242. This advantageously increases the sealing forces between the distalseal 208 and the interior surface of the socket, improving theconnection between the prosthetic liner 204 and the socket. It will alsobe apparent that because the distal seal 208 is located between thedistal end of the liner 204 and the distal interior surface of a socket,loading from the residual limb increases the sealing forces between thesealing portion 256 and the socket.

Optionally, the distal seal 208 can include a plurality of blades 262located along the inner surface of the sealing portion 256 and extendingbetween the sealing portion 256 and the base 242. The blades 262 can bearranged obliquely to an axis C and arranged to collapse against thebase 242 when loaded. The blades 262 may reinforce the distal seal 208to provide a stronger interface between an interior socket wall and theprosthetic liner 204. The blades 262 can also increase the interfacebetween the wall segment 258 and the base 242. The blades 262 can helpcompensate for volume changes in the residual limb by expanding andexerting pressure against an interior surface of a socket to improve theseal around the mechanical lock effected at the attachment pin 230.

The oblique orientation of the blades 262 relative to the axis C permitthe blades 262 to fold toward the base 242 with the possibility of someoverlap over each of the blades 262 as the distal seal 208 engages theinterior socket wall. The blades 262 are at an angle to ensure that eachblade folds in a proper predetermined direction to avoid the creation ofpressure points. The blades 262 are not limited to an obliquelyextending configuration but may be arranged in any number ofconfigurations such as either generally parallel or perpendicular to theaxis C.

FIG. 5 illustrates another embodiment of a distal seal 308 of thepresent disclosure. The distal seal 308 can be like the distal seal 208of the previous embodiments, having a flexible configuration andextending circumferentially about the attachment pin 330. The distalseal 308 includes a base 342 and a sealing portion 356. The base 342 cancomprise a disc or conical member arranged to engage with the distal endor umbrella of a prosthetic liner. The base 342 can be proximate to theattachment pin 330.

A variable clearance 360 is defined between the sealing portion 356 andthe distal end of a prosthetic liner and/or the base 342. Due to thevariable clearance 360 and the flexibility of the distal seal 308, thesealing portion 358 can deflect toward the prosthetic liner and deformwhen it engages the distal interior surface of the socket. The sealingportion 356 is engageable with the interior surface of the socket in amanner similar to that described previously in connection with distalseal 308, bridging or forming a seal between the socket and theprosthetic liner. That is, the form of the sealing portion 356 tends toincrease sealing forces when the distal seal 308 is exposed to apressure differential between the inner and outer sides of the sealingportion 356, with the higher pressure existing towards the inner ordistal side of the sealing portion 356 by pressing the sealing portion356 into engagement with the distal interior surface of the socket.Moreover, the variable clearance 360 and the flexibility of the distalseal 308 helps the distal seal 308 compensate for relative movementbetween the distal interior surface of the socket and the prostheticliner by allowing the sealing portion 356 to better move with and exertpressure against the distal interior surface of the socket to improveand maintain the seal, through a variety of user activities.

In the illustrated embodiment, the sealing portion 356 comprises a wallsegment 358 extending downwardly from an outer portion of the base 342,and a lower segment 362 that extends radially inward from a distal endportion of the wall segment 358. The lower segment 362 includes a firstend connected to the distal end portion of the wall segment 358 and afree end defining an opening 364. The wall segment 358 and the base 342are sized such that the base 342 projects below or distal to the opening364.

As seen, the wall segment 358 can be generally upright or slightlyangled relative to an axis D defined by the distal seal 308 and thelower segment 362 can be generally perpendicular to the axis D. Theradial orientation of the lower segment 362 increases the sealing forcesbetween the sealing portion 356 and the interior surface of the socket,improving the seal. The transecting orientations of the wall segment 358and the lower segments 362 also assist the distal seal 308 inmaintaining its shape as the distal seal 308 flattens when donned andpressed against the socket. Similar to the distal seal 208, the base 342defines a stem 344 that extends from a central portion of the base 342and defines an opening for engagement with an attachment pin 330, and arigid part 348.

FIGS. 6 and 7 illustrate yet another embodiment of a prosthetic socketsystem 400 including a prosthetic liner 404 having an attachment pin430, a sealing system 403 comprising a first seal component 407 adaptedto form a first seal around the mechanical lock of the prosthetic socketsystem 400 and a second seal component 441 adapted to from a second sealbetween the prosthetic liner 404 and a socket, the second seal beinglocated proximal to the first seal. Like the previous embodiment, theprosthetic liner 404 is thus attachable to a socket using both theattachment pin 430 and a vacuum lock or suction in a suspension regiondefined between first and second seals, the prosthetic liner 404, andthe socket. This allows the prosthetic socket system 400 to provide amore secure and stable attachment between the prosthetic liner 404 andthe socket than in prior art systems, improving user confidence andcomfort.

The first seal component 407 comprises a distal seal 408 having aflexible configuration. The distal seal 408 includes a base 442attachable to the prosthetic liner 404 and a sealing portion 456comprising a wall segment 458. The base 442 can comprise a disc orconical member arranged to engage a distal end 424 and/or an umbrella440 of the prosthetic liner 404. The base 442 can be positionedproximate to the attachment pin 430.

A variable clearance 460 is defined between the sealing portion 456 andthe base 442. Due to the variable clearance 460 and a flexibility of thedistal seal 408, the sealing portion 456 can deflect toward a distal end424 of the prosthetic liner 404 and/or the base 442 and deform when itengages the distal interior surface of a socket, forming the first sealbetween the prosthetic liner 404 and the socket. This beneficially sealsaround the attachment pin 430, and consequently allows for vacuum to begenerated between the first seal formed by the distal seal 408 and thesecond seal formed by the second seal component 441. The variableclearance 460 and flexibility of the distal seal 408 help the distalseal 408 compensate for relative movement between the distal interiorsurface of the socket and the prosthetic liner 404 by allowing thesealing portion 456 to better move with and exert pressure against thedistal interior surface of the socket to improve the first seal. Thusthe vacuum does not fail when a user engages in various activities or asthe mechanical attachment shifts, which shifting is minimized by thevacuum.

The sealing portion 456 extends downwardly from the base 442 and has anouter curvature descending to a central opening 464 sized to allow theattachment pin 430 to pass therethrough. A diameter of the centralopening 464 substantially corresponds to a diameter of the attachmentpin 430. As such, the sealing portion 456 is defined along almost theentire outer surface of the distal seal 408, generally covering thedistal end 424 and/or an umbrella 440 on the distal end 424 andincreasing the sealing contact area between the distal seal 408 and asocket. As seen, an inner diameter of the base 442 is greater than thediameter of the central opening 464.

The curved form of the sealing portion 456 advantageously can decreasethe likelihood of the distal seal 408 undesirably sticking to orflattening out against the base 442 when the distal seal 408 is insertedinto a socket. It also provides an increased sealing force between thedistal seal 408 and a socket.

The base 442 can comprise a disc or conical ring adapted to interfacewith and fit against the distal end 424 of the liner 404. The base 442is preferably attachable to the distal end 424 of the prosthetic liner404 via an adhesive such that it can be quickly and efficientlyinstalled on the prosthetic liner 404. For instance, the base 442 can beglued to the distal end 424 of the prosthetic liner 404, forming asealing point or sealing area between the distal seal 408 and theprosthetic liner 404. Moreover, the distal seal 408 can be a separateadd-on module to the prosthetic liner 404 and can fit different liners,providing versatility. Thus existing or conventional liners may beeasily adapted or retrofitted for use with the prosthetic socket system400 of the disclosure.

FIGS. 8 and 9 illustrate yet another embodiment of a prosthetic system500 including a prosthetic liner 504 having an attachment pin 530, and asealing system 503 comprising a first seal component 507 arranged toform a first seal around a mechanical lock between the attachment pin530 and a socket, and a second seal component 541 arranged to form asecond seal between the prosthetic liner 504 and the socket, the secondseal being proximal to the first seal. This allows the prosthetic liner504 to attach to the socket using both a mechanical lock with theattachment pin 530 and elevated vacuum or suction in a sealed orsubstantially sealed region defined between the first and second seals,the prosthetic liner 504, and the socket.

The first sealing component 507 can comprise a distal seal 508 having aflexible configuration and including a base 542 attachable to theprosthetic liner 504, and a sealing portion 556. A variable clearance560 is defined between the sealing portion 556 and the prosthetic liner504 and/or the base 542. Due to the variable clearance 560 and aflexibility of the distal seal 508, the sealing portion 556 can deflecttoward the prosthetic liner 504 and/or the base 542 and deform when itengages the distal interior surface of a socket, forming the first sealbetween the prosthetic liner 504 and the socket. This beneficially sealsaround the mechanical lock between the attachment pin 530 and thesocket, separating the area proximate the mechanical lock andconsequently allows for vacuum to be generated between the distal seal508 and the first seal element 541. The variable clearance 560 and theflexibility of the distal seal 508 helps the distal seal 508 compensatefor relative movement between the distal interior surface of the socketand the prosthetic liner 504 by allowing the sealing portion 556 tobetter move with, comfort to, and exert pressure against the distalinterior surface of the socket to improve the seal.

The sealing portion 556 comprises a wall segment 558 extendingdownwardly from an outer portion of the base 542, and a lower segment562 that extends radially inward from a distal end portion of the wallsegment 558. The lower segment 562 includes a first end connected to thedistal end portion of the wall segment 558 and a free end defining anopening 564. The wall segment 558 and the base 542 are sized such thatthe base 542 terminates above the opening 564, lowering the overallprofile of the distal seal 508. The lower segment 562 and opening 564are sized so that an umbrella 540 of the prosthetic liner 504 projectsbelow the distal seal 508 and the attachment pin 530 exits the umbrella540 below the distal seal 508.

Referring again to the base 542, it can comprise a conical ring adaptedto interface with and fit against a distal end 524 of the prostheticliner 504. The base 542 can be proximate to the attachment pin 530. Thebase 542 is preferably attachable to the distal end 524 and/or anumbrella 540 on the distal end 524 via an adhesive such that it can bequickly and efficiently installed on the prosthetic liner 504. Moreover,like other embodiments, the distal seal 508 can be a separate add-onmodule to the prosthetic liner 504 and can fit different liners,providing versatility.

FIGS. 10 and 11 illustrate yet another embodiment of a prosthetic system600 including a prosthetic liner 604 having an attachment pin 630, and asealing system 603 comprising a first seal component 607 arranged toform a first seal around a mechanical lock between the attachment pin630 and a socket, and a second seal component 641 arranged to form asecond seal between the prosthetic liner 604 and the socket. Theprosthetic liner 604 is attachable to the socket using both theattachment pin 630 and elevated vacuum or suction in a sealed orsubstantially sealed region defined between the first and second seals,the prosthetic liner 604, and the socket.

The first seal component 607 can comprise a distal seal 608 having aflexible configuration and extending circumferentially around theattachment pin 630 and including a sealing portion 656 comprising a wallsegment 658. A variable clearance 660 is defined between the sealingportion 656 and a distal end 624 of the liner 604. Due to the variableclearance 660 and a flexibility of the distal seal 608, the sealingportion 656 can deflect toward the distal end 624 and/or an umbrella 640on the distal end 624 and deform when it engages the distal interiorsurface of a socket, such as when a residual limb is inserted, formingthe first seal between the prosthetic liner 604 and the socket. Thisadvantageously seals around the mechanical lock including the attachmentpin 630, and consequently allows for vacuum to be generated between thefirst seal formed by the distal seal 608 and the second seal formed bythe second seal component 641, without affecting the strength oroperation of the mechanical lock. The variable clearance 660 and theflexibility of the distal seal 608 helps the distal seal 608 compensatefor relative movement between the distal interior surface of the socketand the prosthetic liner 604 by allowing the sealing portion 656 tobetter move with and exert pressure against the distal interior surfaceof the socket to improve and maintain the seal during movements by auser.

A proximal inner surface 666 of the sealing portion 656 is adapted tointerface with and fit against the distal end 624 of the prostheticliner 604. In an embodiment, the proximal inner surface 666 isattachable to the distal end 624 and/or the umbrella 640 via an adhesivesuch that it can be quickly and efficiently installed on the prostheticliner 604. As such, the sealing portion 656 can both form a seal betweenthe prosthetic liner 604 and a socket and connect the distal seal 608 tothe prosthetic liner 604. Moreover, the distal seal 608 can be aseparate add-on module to the prosthetic liner 604 and can fit differentliners, improving versatility, convenience, and affordability.

In an embodiment, the sealing portion 656 extends downwardly from itsattachment to the umbrella 640 and has a conical and/or an outer shapeor curvature descending to a central opening 664 sized to allow theumbrella 640 and attachment pin 630 to protrude through the centralopening 664. A diameter of the opening 664 is greater than the diameterof the attachment pin 630 and smaller than the outer diameter of theumbrella 640.

The sealing portion 656 includes at least one radial seal 668, 670, andpreferably at least two radial seals projecting outwardly from the wallsegment 658. The radial seals are arranged to help maintain connectionwith the interior surface of a socket, improving the reliability of theseal formed by the distal seal 608.

FIGS. 12-17 illustrate a prosthetic socket system 700 according to yetanother embodiment of the present disclosure. The prosthetic socketsystem 700 includes a socket 702, a prosthetic liner 704, and aprosthetic lock assembly 706. The socket 702 has an outer surface 710and an opposing interior surface 712 defining a socket cavity 714. Thesocket cavity 714 includes an open proximal end and a distal end 716.The open proximal end is adapted to receive a distal end of a residuallimb inserted in the socket cavity 714. The distal end 716 defines a pinbore 720 extending therethrough.

The prosthetic liner 704 is configured to be donned on the residual limband positioned in the socket cavity 714. The prosthetic liner 704includes a liner body 722 having a proximal end, which is open, and adistal end 724, which is closed. The liner body 722 defines an innersurface that interfaces with the skin, and an outer surface 728 opposingthe inner surface. The outer surface 728 includes a plurality of sealbands 738. The liner body 722 can be formed of a polymeric orelastomeric material like silicone, copolymer gel, polyurethane,combinations thereof, or the like.

An attachment pin 730 is secured to the distal end 724 of the prostheticliner 704. In an embodiment, the attachment pin 730 is secured to theprosthetic liner 704 via an umbrella 740 connected to or integrated withthe distal end 724. The attachment pin 730 is adapted to extend throughthe pin bore 720 of the socket 702 and thus through the distal end 716of the socket 702. The attachment pin 730 can define a plurality ofnotches, threadings, or serrations 732 (shown in FIG. 14A). Theattachment pin 730 can be mounted to the prosthetic liner 704 orthreaded onto the distal end 724 of the prosthetic liner 704.

The prosthetic lock assembly 706 is configured to connect the residuallimb, indirectly or directly, to the prosthetic socket 702. Preferably,the prosthetic lock assembly 706 includes a lock body 750 configured toattach the prosthetic lock assembly 706 to the socket 702 such that theattachment pin 730 may be inserted in an opening of the lock body 750.The prosthetic lock assembly 706 is shown including a mounting plate 752laminated into the distal end 716 of the socket 702 but may be locatedabove or below the distal end 716 of the socket 702. The prosthetic lockassembly 706 is configured to connect to prosthetic components andeffectively couples the prosthetic liner 704, the socket 702, and othercomponents.

When the attachment pin 730 passes through the pin bore 720 of thesocket 702, the lock body 750 can receive and lock the attachment pin730 therein, which, in turn, mechanically couples the prosthetic liner704 to the socket 702. This mechanical lock or attachment of theprosthetic liner 704 to the socket 702 can be released via a releasemechanism 726 of the prosthetic lock assembly 706. The engagementbetween the attachment pin 730 and the prosthetic lock assembly 706 thusmechanically locks or couples the distal end 724 of the prosthetic liner704 to the distal end 716 of the socket 702, providing a user with safeand reliable suspension.

In addition to the mechanical lock between the prosthetic liner 704 andthe distal end 716 of the socket 702, the prosthetic socket system 700can include a sealing system 703 configured to allow an elevated vacuumor vacuum lock to be generated between the prosthetic liner 704 and thesocket 702 for vacuum suspension.

The sealing system 703 can include at least a first seal component 707.The first seal component 707 can comprise the prosthetic lock assembly706 configured to create both the mechanical lock between the socket 702and the prosthetic liner 704, and a first seal isolating the mechanicallock and/or the pin bore 720 from atmosphere.

The sealing system 703 can also include a second seal component 741. Thesecond seal component 741 can be a movable seal component removablypositioned on the prosthetic liner 704. The second seal component 741includes a body 743 having open upper and lower ends defining an openingtherethrough and an inner surface arranged to abut the outer surface 728of the prosthetic liner 704. The second seal component 741 includes atleast one seal element 745 arranged to engage with the interior surface712 of the socket 702 and form the second seal between the prostheticliner 704 and the socket 702.

The second seal component 741 can frictionally engage at least one ofthe seal bands 738 on the liner body 722 and secure on the outer surface728 of the liner body 722. The second seal component 741 can beselectively positioned on the liner body 722 based on a shape of theresidual limb. In other embodiments, the second seal component 741 canbe moved around on the liner body 722 within a day or period of activityfor relief and/or user comfort.

Optionally, a sleeve 747 having a tubular form is secured to the openupper end of the second seal component 741. The sleeve 747 can have adifferent elasticity from the second seal component 741. For instance,the sleeve 747 can be formed from a textile and the second sealcomponent 741 can be formed from a polymeric material, such as aninjection-molded silicone to form the definitive shape of the secondseal component 741. The sleeve 747 is preferably configured anddimensioned to securely tension over the prosthetic liner 704.

A sealed volume or suspension region B is defined between the first sealelement 707 and the second seal element 741, and between at least aportion of the outer surface 728 of the prosthetic liner 704 and acorresponding portion of the interior surface 712 of the socket 702,substantially isolating this area from atmosphere. According to avariation, a pump system may be fluidly connected with the suspensionregion B. The pump system can be a manual or electrical pump and cancreate an elevated vacuum environment in the suspension region B, which,in turn, provides a vacuum lock or suction tending to retain a residuallimb within the socket 702.

The suspension region B provides a larger attachment area or attachmentlength between the prosthetic liner 704 and the socket 702 than thatprovided by the attachment pin 730 alone. This reduces the likelihood ofproblems that can result when the attachment pin 730 pulls on the distalend 724 of the prosthetic liner 704. For instance, the larger attachmentarea of the suspension region B reduces the likelihood of “pistoning”and “milking” between the residual limb and the socket 702. It alsohelps improve rotational control and stability of the prosthetic socketsystem 700 because the socket 702 and the prosthetic liner 704 are morelikely to move together rather than rotate or displace relative to oneanother during use of the prosthetic socket system 700.

Further, if the vacuum lock or suction in the suspension region B isunexpectedly reduced or lost, the mechanical lock between the attachmentpin 730 and the socket 702 reliably keeps the socket 702 attached to theprosthetic liner 704, preventing the socket 702 from falling of theresidual limb and thereby preventing possible injury. As in previousembodiments, the combination of the mechanical and vacuum lock systemsin the prosthetic socket system 700 provides the individual benefits ofeach system while minimizing the corresponding drawbacks, providingnumerous benefits for users of particular dimensions and conductingdifferent activities, and further enhances comfort and compliant use.

The prosthetic lock assembly 706 comprising the first seal component 707is described in additional detail with reference to FIGS. 13-17 . Asseen, the prosthetic lock assembly 706 includes the lock body 750adapted to attach to the distal end 716 of the socket 702. Referring toFIG. 13 , the lock body 750 can be attached to the distal end 716 of thesocket 702 via one or more fasteners 756 extending through fastenerholes defined in the lock body 750 and threadedly attached to thelamination member 752 mounted in the distal end of the socket 702. Thelock body 750 can be made of any suitable material. The materialselection can depend on desired function. The lock body 750 can beformed of stainless steel, enhancing the durability and stability of thelock body 750. The lock body 750 can include a stiff plastic material, astiff elastomeric material, a metal material, or any other suitablematerial.

The lock body 750 defines a pin hole 760 for receiving the attachmentpin 730, a radial bore 762 intersecting the pin hole 760, and a chamber764 carrying a locking device 754 that selectively locks on theattachment pin 730 and fluidly connects the pin hole 760 and the radialbore 762. The lock body 750 includes an integrated prosthetic adaptor751 defining an internal space 749 having a closed bottom configured andsized to accommodate the attachment pin 730 when the attachment pin 730is inserted in the prosthetic lock assembly 706. Because the adaptor 751is integrated with lock body 750, the build height and weight of theprosthetic lock assembly 706 can be reduced. The internal space 749 canform a lower area of the pin hole 760.

Moreover, the closed distal end of the lock body 750 can help assist auser with donning the prosthetic socket system 700. For instance,engagement between the closed distal end of the lock body 750 and an endof the attachment pin 730 can provide feedback to a user that theattachment pin 730 is fully inserted in the prosthetic lock assembly706, assisting with donning the prosthetic socket system 700. In otherembodiments, the internal space 749 defined by the lock body 750 canhave an open bottom. For instance, the attachment pin 730 can passthrough a pressed sealing ring carried in the lock body 750 that sealsagainst the attachment pin 730 and separates the chamber 764 fromatmosphere.

A locking device 754 is arranged to unidirectionally and selectivelylock the attachment pin 730 in the lock body 750 while permittinginsertion of the attachment pin 730 in the lock body 750. The lockingdevice 754 also actuates a valve assembly described below, the valveassembly arranged to allow air or other fluid to enter the lock body 750and the suspension region B. The locking device 754 can have anysuitable shape and defines a through hole allowing the attachment pin730 to pass therethrough. The through hole can be oversized relative toa diameter of the attachment pin 730 such that the locking device 754can translate back and forth relative to the attachment pin 730 when theattachment pin 730 is inserted in the through hole.

As seen in FIG. 14B, the locking device 754 defines a pin engagementpart 786 configured to unidirectionally lock the attachment pin 730 inthe lock body 750 while permitting insertion of the attachment pin 730in the lock body 750. More particularly, the pin engagement part 786 isconfigured such that as the attachment pin 730 moves through the pinhole 760, sliding contact between the pin engagement part 786 and theattachment pin 730 moves the locking device 754 within the chamber 764and permits insertion of the attachment pin 730 in the pin hole 760.Interaction between the pin engagement part 786 and the attachment pin730 in the pin hole 760 can also unidirectionally lock the attachmentpin 730 in the lock body 750.

For instance, when the pin engagement part 786 is captured betweenadjacent serrations 732 of the attachment pin 730, the pin engagementpart 786 can unidirectionally lock the attachment pin 730 in the lockbody 750. A release mechanism 726 is positioned in the radial bore 762on a side of the locking device 754 opposite of a valve assembly 766described below. The release mechanism 726 is manually operable todisengage the locking device 754 from the attachment pin 730 and tooperate the valve assembly 766.

The locking device 754 is shown comprising a shuttle lock but cancomprise any suitable locking device. For instance, the locking device754 can comprise a ratchet type lock having a pawl member configured toengage the serrations 732 on the attachment pin 730. The releasemechanism 726 can be releasably connected to the pawl member todisengage the pawl member from the attachment pin 730 and operate thevalve assembly 766.

In addition to the mechanical lock, the buildup and release of vacuumbetween the socket 702 and the prosthetic liner 704 can be controlledthrough the prosthetic lock assembly 706. This beneficially eliminatesthe need for a separate port defined in the socket 702 and/or a separatevalve to permit expulsion of fluid or air from the suspension region B,reducing the overall weight and complexity of the socket 702 especiallywhen configuring it with a conventional or existing prosthetic socketsystem. As described below, the prosthetic lock assembly 706 selectivelyisolates the suspension region B from atmosphere and can be passive andactive vacuum compatible.

To permit expulsion of fluid (e.g., air) from the suspension region B,the prosthetic lock assembly 706 can include one or more one-way valves.In an embodiment, two one-way valves 768, 770 positioned in the lockbody 750 are in fluid communication with the chamber 764, which, inturn, is in fluid communication with the suspension region B via the pinbore 720 of the socket 702. In the illustrated embodiment, the one-wayvalves 768, 770 are located on opposite sides of the valve assembly 766.Each of the one-way valves 768, 770 preferably includes a duckbill valve774, 775 that only allows air or other fluids to exit the chamber 764.It should be appreciated, however, that other types of one-way valvesare possible. A port 769 is coupled to the one-way valve for coupling toa pump system.

The one-way valve 768 is configured to facilitate the buildup of anactive vacuum in the suspension region B. For instance, the one-wayvalve 768 can be configured for connection to a pump system. When thepump system applies a vacuum to the chamber 764 via the one-way valve768, fluid is drawn from the chamber 764 and the suspension region B,applying a vacuum in the suspension region B. Air can be evacuated fromthe suspension region B through the one-way valve 768 in severaldifferent ways including, but not limited to, a hand pump, an electronicpump, or a mechanical pump activated by the motion of the user walking,for example. The prosthetic lock assembly 706 is thus passive and activevacuum compatible so that a vacuum can be drawn through the prostheticlock assembly 706 rather than through a separate port defined in thesocket 702, simplifying the cost, complexity, and operation of theprosthetic socket system 700.

The one-way valve 770 can be configured as a one-way expulsion valve,only permitting fluid to be expelled out of the suspension region B andthe chamber 764, preferably to atmosphere. The one-way valve 770preferably has a low opening pressure such that the prosthetic lockassembly 706 can automatically expel air from the suspension region Bwhile a user is donning the prosthetic socket system 700 or ambulating.The lock body 750 defines one or more internal passageways 772 providingfluid communication between the chamber 764 and the one-way valves 768,770.

The valve assembly 766 is positioned in the lock body 750 opposite therelease mechanism 726. The valve assembly 766 extends into and isfluidly connected to the chamber 764. In an embodiment, the valveassembly 766 is recessed within an opening formed in the lock body 750.The valve assembly 766 is operable to allow air or other fluid to enterthe suspension region B via the valve assembly 766, releasing a vacuumin the suspension region B.

As seen, the valve assembly 766 comprises a valve body 766A defining apassageway 766B extending therethrough. The valve body 766A carries apin member 766C and a spring member 766D. The pin member 766C defines ahead portion 766E and extends from the valve body 766A so that the pinmember 766C can selectively engage with the locking device 754. Thepassageway 766B includes an enlarged portion that defines a seat 766Ffor the head portion 766E of the pin member 766C. Generally, when thehead portion 766E engages or contacts the seat 766F, the valve assembly766 is in a closed position (shown in FIG. 14B). In the closed position,the head portion 766E is forced against the seat 766F by the spring 766Dto prevent fluid flow through the valve assembly 766.

When the head portion 766E is disengaged from the seat 766F, the valveassembly 766 is in an open position. In the open position, thepassageway 766B is unsealed and fluid communication between thesuspension region B and atmosphere via the passageway 766B isestablished, allowing air or other fluid to enter the suspension regionB. This has the effect of releasing a vacuum in the suspension region B.

The spring member 766D is adapted to bias the valve assembly 766 towardthe closed position. For instance, in the closed position, the springmember 766D biases the head portion 766E toward the seat 766F of thevalve body 766A, sealing the valve assembly 766 and creating a fluidseparation between atmosphere and the suspension region B. When therelease mechanism 726 moves the valve assembly 766 from the closedposition toward the open position, the head portion 766E compresses orfurther compresses the spring member 766D between the head portion 766Eand another component (e.g., the valve body 766A). When the load appliedto the release mechanism 726 is released, stored energy in the springmember 766D can force the head portion 766E back into the seat 766F toreturn the valve assembly 766 to the closed position. Thus, the springmember 766D can help automatically close the valve assembly 766. Thevalve assembly 766 can comprise a pin valve, a needle valve, a bicyclevalve, a membrane valve, a bladder, or any other suitable type of valve.

Manual operation of the release mechanism 726 translates the lockingdevice 754 in the lock body 750 to unlock the attachment pin 730 fromthe lock body 750 and to move the valve assembly 766 to the openposition, which, in turn, releases a vacuum in the suspension region B.The release mechanism 726 thus releases both the mechanical lock and thevacuum lock of the prosthetic socket system 700. The release mechanism726 is preferably arranged to unlock the attachment pin 730 and vacuumin the suspension region B with a single action. This simplifiedoperation of the release mechanism 726 is particularly advantageous forelderly or other users having limited dexterity and/or strength.

One or more, as in supplementary first and second, spring members 758engaging the locking device 754 in the chamber 764 are arranged to biasthe locking device 754 away from the valve assembly 766. The springmembers 758 can be selected such that the release mechanism 726 can beoperated with a reduced force. For instance, the spring members 758 canbe sized and configured such that the release mechanism 726 workingagainst the spring members 758 can be operated with a release force lessthan between about 50 N and about 70 N (e.g., 60 N). A handle 729 ispreferably provided on the rod 727 to assist operation thereof.

Referring to FIG. 14A, a central opening 753 is defined in the mountingplate 752 that is oversized and configured to receive the attachment pin730. For instance, the mounting plate 752 can define the central opening753 and includes an annular flange 753A surrounding the central opening753 and extending axially upward and radially away from a top of thecentral opening 753 as shown. The annular flange 753A can help funnel orguide the attachment pin 730 into the pin hole 760. This advantageouslymakes donning the socket 702 easier. This annular flange 753A can alsohelp forgive poor alignment of the prosthetic liner 704 within thesocket 702. This is beneficial as the user does not have to “thread theneedle,” which increases the risk of incorrect attachment and injury,but rather the user is provided with an intuitive and forgivingattachment means. The annular flange 753A can define a surface arrangedto interact with an umbrella 740 or the distal end 724 of the prostheticliner 704. In an embodiment, the mounting plate 752 can include atwo-part construction. For instance, the mounting plate 752 can includean outer part 752A and an inner part 752B threadedly attached to theouter part 752A. A cover member 776 is positioned under the mountingplate 752 and includes an opening 782 arranged to align the attachmentpin 730 within the lock body 750.

A seal member 774 may be provided between the outer part 752A and theinner part 752B to ensure a seal therebetween. The mounting plate 752 issealed to the cover member 776 by a sealing member 778, and the covermember 776 is sealed to the lock body 750 by a sealing member 780. Therelease mechanism 726 is sealed in the radial bore 762 by a plurality ofsealing members 784. These sealing members may comprise O-rings and canhelp ensure that fluid (e.g., air) can only enter the chamber 764 viathe valve assembly 766 and can only exit the chamber 764 via the one-wayvalves 768, 770. In an embodiment, the prosthetic lock assembly 700 hasa waterproof configuration. For instance, the sealing members 778, 780,784 in combination with the closed bottom of the lock body 750, canprevent water from entering the socket 702 via the pin bore 720,improving reliability and hygiene of the prosthetic socket system 700.

The sealing members 778, 780, 784 in combination with the closed bottomof the lock body 750, additionally help the prosthetic lock assembly 706to work using different types of prosthetic liners. More particularly,because the prosthetic lock assembly 706 does not need a physical sealagainst the attachment pin 730 for a vacuum lock within the suspensionregion B, the vacuum lock formed by the prosthetic lock assembly 706 isindependent from the presence of the attachment pin 730. The mechanicallock formed by the prosthetic lock assembly 706 with the attachment pin730 is also independent of the vacuum lock. As such, the prosthetic lockassembly 706 does not need a prosthetic liner with an attachment pin tomaintain a vacuum lock. Further, the prosthetic lock assembly 706 doesnot need a vacuum lock to form a mechanical lock with the attachment pin730. The prosthetic lock assembly 706 thus offers users and cliniciansgreat versatility in selecting a prosthetic liner.

For instance, a clinician may instruct a user to wear a lockingprosthetic liner (e.g., a liner including only an attachment pin) oneday using the prosthetic lock assembly 706, a suction type prostheticliner (e.g., a liner including only a seal element) another day usingthe prosthetic lock assembly 706, and a suction-locking prosthetic liner(e.g., a liner including a seal element and attachment pin) yet anotherday using the prosthetic lock assembly 706. This dual or alternatesuspension capability of the prosthetic lock assembly 706 allows theprosthetic lock assembly 706 to be used with different prosthetic linersas needed or desired, and as best suits a user's needs and activities.

In use, the prosthetic lock assembly 706 is movable between differentpositions and configurations for selectively controlling the mechanicaland vacuum lock between the prosthetic liner 704 and the socket 702.With the attachment pin 730 separate from the lock body 750 and therelease mechanism 726 unengaged, the prosthetic lock assembly 706 can bein an unlocked position as shown in FIGS. 14A and 14B. In the unlockedposition, the pin engagement part 786 of the locking device 754 is atleast partially located in the pin hole 760 between the internal space749 of the lock body 750 and the central opening 753. This ensures thatthe attachment pin 730 will engage the pin engagement part 786 of thelocking device 754 as it passes through the pin hole 760. The lockingdevice 754 can be engaged with the release mechanism 726 and disengagedfrom the valve assembly 766.

Engagement between the locking device 754 and the attachment pin 730moves the prosthetic lock assembly 706 toward a loading position whenthe attachment pin 730 is partially inserted in the pin hole 760 of thelock body 750 as shown in FIGS. 15A and 15B.

In the loading position, the attachment pin 730 engages with the pinengagement part 786 of the locking device 754 as the attachment pin 730moves through the pin hole 760, which, in turn, pushes the lockingdevice 754 in a first direction or away from the release mechanism 726and toward the valve assembly 766. The pin engagement part 786 cancomprise an inclined or conical upper surface so that sliding contactbetween the attachment pin 730 and the upper surface of the pinengagement part 786 drives the locking device 754 in the firstdirection.

As the locking device 754 moves in the first direction, the lockingdevice 754 compresses the spring members 758 between the locking device754 and the lock body 750. The valve assembly 766 is initially in theclosed position, preventing air from entering the chamber 764 via thevalve assembly 766. According to a variation, as the attachment pin 730is inserted in the lock body 750, a pressure increase in the chamber 764can open the one-way valve 770, expelling air out of the prosthetic lockassembly 706. In the locked position, the locking device 754 can bedisengaged from both the release mechanism 726 and the valve assembly766.

Referring to FIGS. 16A and 16B, when the pin engagement part 786 isaligned between adjacent serrations 732 on the attachment pin 730 and/orthe attachment pin 730 is fully inserted in the pin hole 760, theprosthetic lock assembly 706 can move to a locked position. In thelocked position, stored energy in the spring members 758 forces thelocking device 754 in a second direction opposite the first direction ortoward the attachment pin 730, which, in turn, drives the pin engagementpart 786 in a corresponding space between adjacent serrations 732 on theattachment pin 730. This engagement of the pin engagement part 786between the serrations 732 locks the attachment pin 730 in theprosthetic lock assembly 706, forming a mechanical lock between theprosthetic liner 704 and the socket 702. It will be appreciated that thedistribution of the serrations 732 along a length of the attachment pin730 allows the locking device 754 to lock the attachment pin 730 in thelock body 750 at different positions or heights. The locking device 754can be disengaged from both the release mechanism 726 and the valveassembly 766 in the locked position.

Optionally, the prosthetic lock assembly 706 can be arranged to providea user feedback when the prosthetic lock assembly 706 moves into thelocked position. For instance, a hardness of the pin engagement part 786or the attachment pin 730 can be selected to produce a click or knockwhen the pin engagement part 786 contacts the attachment pin 730 betweenadjacent serrations 732, providing feedback to the user that theprosthetic liner 704 is correctly or securely positioned in the socket702. While the attachment pin 730 is described as including serrations732, in other embodiments, the locking device 754 can be arranged toselectively interact with and lock an attachment pin having a flat,smooth, or other configuration.

With the prosthetic lock assembly 706 is in the locked position, theone-way valve 768 can facilitate the creation of a vacuum lock in thesuspension region B. For instance, a pump system can be fluidlyconnected to the suspension region B via the one-way valve 768 on thelock body 750 and operated to create an elevated vacuum environment inthe suspension region B, which, in turn, can form a vacuum lock betweenthe socket 702 and the prosthetic liner 704 in addition to themechanical lock between the residual limb and the socket 702. The pumpsystem can be connected to the one-way valve 768 via a tube or in anyother suitable manner.

Referring to FIGS. 17A and 17B, the release mechanism 726 can move theprosthetic lock assembly 706 to a release position in which themechanical lock and the vacuum lock are released. In use, the releasemechanism 726 may be pushed into the lock body 750 so that the rod 727urges the locking device 754 in the first direction or toward the valveassembly 766, which, in turn, disengages the pin engagement part 786from between a space between adjacent serrations 732 on the attachmentpin 730. This allows upward axial movement of the attachment pin 730within the prosthetic lock assembly 706, releasing the mechanical lock.

As the rod 727 urges the locking device 754 further in the firstdirection, the locking device 754 can engage with and drive the pinmember 766C of the valve assembly 766 toward the valve housing 766A,which, in turn, separates the head portion 766E of the pin member 766Cfrom the seat 766F of the valve housing 766A. This moves the valveassembly 766 to the open position, allowing air to enter the suspensionregion B via the valve assembly 766, releasing the vacuum lock.

The prosthetic lock assembly 706 is preferably arranged such that therelease mechanism 726 releases the mechanical lock between the lockingdevice 754 and the attachment pin 730 before releasing the vacuum lockin the suspension region B. More particularly, the rod 727 may be pushedinto the lock body 750 to first urge the locking device 754 in the firstdirection away from the attachment pin 730, releasing the mechanicallock, and then to urge the head portion 766E of the pin member 766C awayfrom a seat 766F defined by the valve body 766A, allowing air to enterthe chamber 764 via the valve assembly 766, which is then able to travelthrough the opening 782 which is now open because of the attachment pin730 being moved.

The release mechanism 726 can thus release the mechanical and vacuumlocks of the prosthetic socket system 700 with a single action. Thisbeneficially facilitates doffing of the socket 702 as good handdexterity and/or strength are not required to operate the prostheticlock assembly 706. Rather, the prosthetic liner 704 can be securelyattached to the socket 702 and easily released from the socket 702 witha simple manipulation of the release mechanism 726. When the releasemechanism 726 moves the valve assembly 766 to the open position, thespring members 758 are further compressed relative to the compression ofthe spring members 758 in the locked position.

When the attachment pin 730 is removed from the lock body 750 and therelease mechanism 726 is released, stored energy in the spring members758 forces the locking device 754 back in the second direction,returning the prosthetic lock assembly 706 toward the unloaded position.Simultaneously or near simultaneously, stored energy in the springmember 766D on the pin member 766C forces the valve assembly 766 towardthe closed position, resealing the chamber 764 and the consequentlysuspension region B.

According to a variation, the prosthetic lock assembly 706 can move to amechanical release only position. For example, the rod 727 of therelease mechanism 726 may be pushed into the lock body 750 a selecteddistance to urge the locking device 754 in the first direction away fromthe attachment pin 730, thereby disengaging the pin engagement part 786from the serrations 732 of the attachment pin 730, but short of anactuating engagement with the pin member 766B of the valve assembly 766,leaving the valve assembly 766 in the closed position. This allows theprosthetic socket system 700 to release the mechanical lock between theprosthetic liner 704 and the socket 702 when the release mechanism 726is partially depressed without releasing the vacuum lock. Such anarrangement can reduce the likelihood of the socket 702 unexpectedlyfalling off the residual limb due to accidental contact with the releasemechanism 726, and allows a user to easily and intuitively use theprosthetic socket system 700 according to their particular needs at anygiven time.

The prosthetic lock assembly 706 thus controls mechanical and vacuumsuspension in the prosthetic socket system 700, providing more secureand reliable suspension to a user. Further, the release mechanism 726 isoperable to release both the mechanical lock between the attachment pin730 and the locking device 754, and the vacuum lock in the suspensionregion B in a single action. Moreover, the release mechanism 726 canrelease the mechanical lock of the prosthetic socket system 700 prior toreleasing the vacuum lock, improving user safety.

FIGS. 18-20 illustrate yet another embodiment of prosthetic liner 804 ofthe present disclosure. The prosthetic liner 804 includes a liner bodyhaving a proximal end, which is open, and a distal end 824 which isclosed. The liner body defines an inner surface that interfaces with theskin, and an outer surface opposing the inner surface. The outer surfacecan include a plurality of seal bands 838 arranged to frictionallyengage with a movable seal component positionable on the prostheticliner 804. The distal end 824 includes an umbrella 840 that can beattached to or integrated with the distal end 824 of the prostheticliner 804. The umbrella 840 is arranged to mount an attachment pin tothe distal end 824 via a stem portion defining a threaded opening 888.

As discussed above, when the attachment pin is inserted in a prostheticlock assembly 806 of the present disclosure, the umbrella 840 mayinteract with a mounting plate 852 of the prosthetic lock assembly 806.In certain devices, this interaction between the umbrella 840 and themounting plate 852 can cause the umbrella 840 to seal or stick againstthe prosthetic lock assembly 806. Disadvantageously, this can interferewith or prevent a vacuum in a suspension region between the socket andthe prosthetic liner 804 because air cannot move between the umbrella840 and the prosthetic lock assembly 806, such as when air or otherfluid is being evacuated from the space between the prosthetic liner andthe socket.

In the illustrated embodiment, the distal end 824 of the prostheticliner 804 defines a plurality of flow channels 890. In the illustratedembodiment, the flow channels 890 can be distributed circumferentiallyabout the distal end 824 and extend generally in a radial directionalong the distal end 824. Other configurations, paths, and shapes arepossible. The flow channels 890 can be defined in the umbrella 840. Theflow channels 890 can be generally linear. The flow channels 890 cancomprise recesses defined in the distal end 824, or alternatively maycomprise protruding portions formed in the distal end 824.

When the prosthetic liner 804 is positioned in a socket and on theprosthetic lock assembly 806, the flow channels 890 define flow pathsalong the surface of the distal end 824 into which air or other fluidscan flow between the suspension region in the socket and a chamber ofthe prosthetic lock assembly 806 as seen in FIG. 19 . This improved flowof fluid (e.g., air) between the distal end 824 and the prosthetic lockassembly 806 helps prevent the distal end 824 from sealing or stickingon the prosthetic lock assembly 806, which, in turn, allows theprosthetic lock assembly 806 to more effectively and timely build up andrelease vacuum or a vacuum lock in the suspension region.

FIG. 21 illustrates yet another embodiment of a prosthetic liner 904according to the present disclosure including a plurality of flowchannels 990. As seen, a distal end of the prosthetic liner 904 includesan umbrella 940 defining the flow channels 990. The flow channels 990are distributed circumferentially about the umbrella 940 and extendgenerally in a radial direction. The flow channels 990 can extendcompletely or partially between a stem portion 988 of the umbrella 940and an outer edge of the umbrella 940. In other embodiments, the flowchannels 990 can be distributed about only a portion of the umbrella 940or the distal end.

As seen in the depicted embodiment, the flow channels 990 can curvealong a length of the flow channels 900 and/or along a length orlocation of the umbrella 940. According to a variation, the flowchannels 990 can have a branched configuration including primarysegments and secondary segments branching from the primary segments,allowing the flow channels 990 to extend in different directions. Theprimary segments can be fluidly connected to the outer edge of theumbrella 940. The primary and second segments can have varyingcross-sectional areas. For instance, the primary segments can have alarger cross-sectional area than the secondary segments extending fromthe primary segments, varying the flow rate and/or flow velocity of airor other fluid moving through the flow channels 990.

Like above, the flow channels 990 improve fluid flow between the distalend 924 and a prosthetic lock assembly, which, in turn, allows theprosthetic lock assembly to more effectively build up and release vacuumin a suspension region defined between the prosthetic liner 904 and asocket. The inclusion of primary and secondary segments allows for fluidto be effectively and evenly removed from a suspension region whileminimizing the overall volume and profile of the flow channels 990within the umbrella 940 and between the prosthetic liner and the socket.

By providing a prosthetic system comprising a combination of mechanicaland vacuum locks according to embodiments of the disclosure, a user maybenefit from an enhanced attachment between the prosthetic liner and aprosthetic socket, combining the strength and stability, for example, ofa mechanical lock with the comfort and added security of a vacuum lockor seal, while also mitigating the downsides associated with each typeof attachment, such as “milking,” “pistoning,” and associated ailments.This arrangement benefits a wide number of user needs and conditions,and also offers a simple, intuitive, and reliable method for donning anddoffing the prosthetic socket system. The prosthetic socket system isfurther adapted to conveniently and simply be arranged with existingand/or conventional liners and sockets, for added versatility andreduced cost.

It is to be understood that not necessarily all objects or advantagesmay be achieved under any embodiment of the disclosure. Those skilled inthe art will recognize that the orthopedic device may be embodied orcarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otherobjects or advantages as may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features. In addition to the variations described herein,other known equivalents for each feature can be mixed and matched by oneof skill in this art to construct a prosthetic socket system inaccordance with principles of the present disclosure. It will beunderstood by the skilled artisan that the features described herein mayapply to other types of orthopedic, prosthetic, or medical devices.

Although this disclosure describes certain exemplary embodiments andexamples of a prosthetic socket system, it nevertheless will beunderstood by those skilled in the art that the present disclosureextends beyond the specifically disclosed prosthetic socket embodimentsto other alternative embodiments and/or users of the disclosure andobvious modifications and equivalents thereof. It is intended that thescope of the present disclosure should not be limited by the particulardisclosed embodiments described above, and may be extended to prostheticdevices and supports, and other applications that may employ thefeatures described herein.

The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting. Additionally, thewords “including,” “having,” and variants thereof (e.g., “includes” and“has”) as used herein, including the claims, shall be open ended andhave the same meaning as the word “comprising” and variants thereof(e.g., “comprise” and “comprises”).

The invention claimed is:
 1. A prosthetic lock assembly comprising: alock body having a pin hole adapted to receive an attachment pin, thelock body further defining a radial bore intersecting the pin hole, anda chamber carrying a locking device that selectively locks to theattachment pin and fluidly connects the pin hole and the radial bore tounidirectionally lock the attachment pin in the lock body whilepermitting insertion of the attachment pin in the lock body; a valveassembly positioned in the lock body, the valve assembly moveablebetween a closed position in which the valve assembly is sealed, and anopen position in which the valve assembly is unsealed so that air movesinto the lock body via the valve assembly; and a release mechanismpositioned in the radial bore on a side of the locking device oppositeof a valve assembly, the release mechanism arranged to both release thelocking device from the attachment pin and move the valve assembly tothe open position by translating the locking device in the lock body;wherein the valve assembly includes a pin member arranged to selectivelyengage with the locking device and move the valve assembly between theopen and closed positions; wherein the valve assembly includes a valvehousing carrying the pin member, and a spring member biasing the valveassembly toward the closed position, the spring member located on andabout the pin member; wherein that the valve housing defines a seatarranged to engage a head portion of the pin member when the valveassembly is in the closed position; wherein a pin engagement part isconfigured to unidirectionally lock the attachment pin in the lock bodywhile permitting insertion of the attachment pin in the lock body, thepin engagement part is configured such that as the attachment pin movesthrough the pin hole, sliding contact between the pin engagement partand the attachment pin moves the locking device within the chamber andpermits insertion of the attachment pin in the pin hole; wherein therelease mechanism is arranged to be pushed into the lock body to urgethe locking device in a first direction or toward the valve assembly anddisengage a pin engagement part of the lock body from between a spacebetween adjacent serrations on the attachment pin thereby allowingupward axial movement of the attachment pin within the prosthetic lockassembly; wherein the release mechanism is arranged to urge the lockingdevice further in the first direction, the locking device adapted toengage with and drive the pin member of the valve assembly toward thevalve housing, to separate the head portion of the pin member from theseat of the valve housing, and to move the valve assembly to the openposition; wherein the prosthetic lock assembly further comprises firstand second supplementary spring members positioned between the lockingdevice and the lock body in the chamber, the first and secondsupplementary spring members arranged to bias the locking device awayfrom the valve assembly and are located parallel to and on opposed sidesof the pin member and the spring member thereon, wherein when theattachment pin is removed from the lock body and the release mechanismis released, stored energy in the first and second supplementary springmembers force the locking device back in a second direction opposite thefirst direction, returning the prosthetic lock assembly toward anunloaded position, and simultaneously, stored energy in the springmember on the pin member forces the valve assembly toward the closedposition, thereby resealing the chamber; wherein the prosthetic lockassembly further comprises first and second one-way valves positionedparallel to the pin member in the lock body and perpendicular to the pinengagement part and in fluid communication with the chamber; wherein thefirst one-way valve is configured to couple to a pump system foractively facilitating a build-up of an active vacuum in a suspensionregion between a socket and liner, a port extending from the firstone-way valve for coupling to the pump system; wherein the secondone-way valve is configured as a one-way expulsion valve adapted topermit expulsion of fluid from the suspension region between the socketand the liner, the second one-way valve including a duckbill valve, thesecond one-way valve including a low opening pressure such that theprosthetic lock assembly is arranged to automatically expel air from thesuspension region while a user is donning the socket and the liner orambulating; wherein first and second first and second one-way valves,and the pin member open on a same side of the lock body.
 2. Theprosthetic lock assembly of claim 1, wherein the release mechanism isarranged to release the locking device from the attachment pin and movethe valve assembly to the open position in a single action.
 3. Theprosthetic lock assembly of claim 1, wherein the release mechanism isarranged to release the locking device from the attachment pin beforemoving the valve assembly to the open position.
 4. The prosthetic lockassembly of claim 1, wherein the release mechanism is operable torelease the locking device from the attachment pin without moving thevalve assembly to the open position.
 5. The prosthetic lock assembly ofclaim 1, wherein the lock body includes a prosthetic adaptor defining aninternal space having a closed bottom configuration for accommodatingthe attachment pin when the attachment pin is inserted in the lock body.6. The prosthetic lock assembly of claim 1, wherein the lock body isarranged to provide a seal around a mechanical lock formed between thelock body and the attachment pin.
 7. The prosthetic lock assembly ofclaim 1, wherein the release mechanism includes a rod arranged toreleasably engage with the locking device.